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The race against superbugs Investing to develop new antibiotics and other life-saving products to treat drug-resistant bacteria. Annual Report 2016-2017
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Page 1: The race against superbugs - Carb-Xbacteria have a single membrane barrier that is relatively easy to penetrate, so many types of antibiotics get into the cell. Discovery of novel

The raceagainst superbugs

Investing to develop new antibiotics and other life-saving products to treat drug-resistant bacteria.

Annual Report 2016-2017

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| ANNUAL REPORT 2016-20172

VisionProtect humanity from the most serious threats from drug-resistant bacterial infections.

MissionAccelerate a diverse portfolio of at least 20 high-quality antibacterial products towards clinical development focusing on the priority bacterial pathogens identified by the WHO and CDC.

CARB-X was created in response to the US government’s 2015 Combating Antibiotic Resistant Bacteria (CARB) initiative and the UK government’s call in 2016 for a concerted global effort to tackle antibiotic resistance.

A non-profit partnership headquartered at Boston University, CARB-X was launched July 28, 2016, by two divisions of the US Department of Health and Human Services: the Biomedical Advanced Research and Development Authority, a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR/BARDA) and the National Institute of Allergy and infectious Diseases, part of the National Institutes of Health (NIAID/NIH). Current funders are Wellcome Trust and BARDA. NIAID provides preclinical services.

Other partners include the Broad Institute of MIT and Harvard, the Massachusetts Biotechnology Council (MassBio), the California Life Sciences Institute (CLSI), and RTI International.

CARB-X projects are selected through a global competitive process. Applications are vetted by the CARB-X Science Advisory Board, comprised of leading antibiotic and diagnostic professionals as well as experts in other modalities including vaccines, microbiome, phage and immunology. To be considered, projects must target one of resistant bacteria on the Serious or Urgent Threat List issued by the CDC or on the Priority Pathogens list published by the WHO.

BARDA funding is provided to CARB-X under Cooperative Agreement 6 IDSEP160030-02-01.

Boston University, home of CARB-X

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ANNUAL REPORT 2016-2017 | 3

2016-2017 Highlights 4Solving the Superbug Threat 6Joint Oversight Committee 12Science Advisory Board 13

Financials 14

85

910

How CARB-X woRksGlobal non-profit public private partnership funding and supporting pre-clinical researchMessAge fRoM tHe

eXeCutive DiReCtoRA Year of Progress

and Hope

gReAt sCienCe knows no BounDARiesBattling drug-resistant bacteria with promising research from around the world

CARB-X PoRtfolioGrowing portfolio of

18 pre-clinical research projects in six countries,

with more to come

Table of contents

Photo credits: U.S. Centers for Disease Control and Prevention

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CARB-X is investing $455 million over five years into the research and development of new antibiotics, rapid diagnostics and other life-saving products to tackle the global threat of drug-resistant bacteria. CARB-X is a non-profit public-private partnership established in July 2016 at Boston University.

A first year of achievement2016-2017 Highlights • $41.6 million announced to help fund antibacterial pre-clinical research projects plus an additional $52.6 if project milestones are met

• Targeting the most urgent drug-resistant gram-negative bacteria, as prioritized by the WHO and CDC

• 18 innovative projects funded, all potential game-changers in fight against drug-resistant bacteria. More projects to come in late 2017

• 8 new classes of antibiotics in the pipeline

• Projects selected through highly competitive process by independent panel of more than 60 world-renowned scientific advisors

• 368 applications received from researchers around the world

• Providing fully non-dilutive funding, with wrap around business support services from from world leading life-science accelerators

• Efficient low-cost structure with more than 96% of budget in first year injected directly into research funding

• Global reach expanding with funded projects in 6 different countries and no geographic restrictions on funding

2016 -17

| ANNUAL REPORT 2016-20174

“R&D initiatives such as CARB-X are absolutely critical in addressing antimicrobial resistance as a global health challenge. GARDP is pleased to collaborate with CARB-X as part of a global effort to ensure the development of new antibiotics and diagnostics, as well as to ensure access to and stewardship of new drugs.”

— Dr. Manica BalasegaramDirector, Global Antibiotic Research and Development Partnership (GARDP),

a Joint DNDi / WHO initiative

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ANNUAL REPORT 2016-2017 | 5

For antibiotics, “business as usual” isn’t working. CARB-X breaks the mold, because we need radical innovation to defeat drug-resistant infections.

CARB-X makes portfolio investments like a venture capital fund, but we are non-dilutive and non-profit. Many inves-tors want to see a return on investment in a few years; we take the long view, prioritizing sustainable health security for everyone against the threat of drug-resistant infections.

For our core executive team, this isn’t just a job, but a mission. We’ve seen first-hand how infections can ravage good health, even for the young. One of my grandchildren needed powerful antibiotics in the first week of life in the NICU at Boston Children’s Hospital. Some of us lost jobs as big pharma re-treated from antibiotics, or have strug-gled to treat patients when nothing was left that still worked. The CARB-X team knows from history what life was like before antibiotics and we work hard so the next generations don’t learn about the post-antibiotic era from personal experience.

We also approach this project with humility. Experts are often wrong, so we invest in a broad range of technologies and teams, even if opinions differ. Drug development is fraught with failure, so we want many, many shots on goal. And we listen carefully: to the companies we fund; to the experts on our Science Advi-sory Board; to external stakeholders and critics; to our funders, partners and med-ical professionals; and especially to the patients around the world who desper-ately need safe and effective treatments. Listening helps us to learn, and therefore improve how we support the innovative projects that could potentially become life-saving treatments for the future.

CARB-X is a rare opportunity to actual-ly achieve tangible progress in global health. We’re not throwing away our shot. We have achieved solid progress in our first year and we will continue to work closely with our partners to build our pipeline and our global reach to accelerate the delivery of new products.

kevin outtersonExecutive Director, CARB-X

A Year of Progress and Hope

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| ANNUAL REPORT 2016-20176

solving the superbug threatDrug resistant bacteria is a global public health threat that is getting worse. An estimated 700,000 people die each year around the world from drug-resistant bacteria, according to the World Health Organization (WHO). In the US alone, the Centers for Disease Control and Prevention (CDC) estimates that 23,000 people die each year, and the European Centre for Disease Preven-tion and Control (ECDC) estimates that 25,000 people die annually in Europe.

Many advances of modern medicine — joint replace-ments, organ transplants, cancer therapy, and treatment of chronic diseases such as diabetes, asthma, rheuma-toid arthritis — are dependent on the ability to fight infections with antibiotics. If that ability is lost, the ability to safely offer people many life-saving and life-improving modern medical advantages will also be lost.

Part of the solution is to accelerate the development of new drugs to treat drug-resistant infection. No newly approved classes of antibiotics have been discovered since 1962 for the most dangerous types of bacte-ria – Gram negatives, and innovations to improve the diagnosis and prevention of drug-resistant infections have been slow.

Most large drug companies have reduced or aban-doned infection research due to scientific challenges, and because it has become impossible for them to recoup the cost of research.

The economic model that once meant we could rely on industry for a steady supply of new antibiotics sim-ply no longer works. At the same time, the deadliest superbugs have been rapidly developing resistance to existing antibiotics, hastened by overuse and misuse in humans and animals. It takes on average 10 years and hundreds of millions of dollars to develop a new drug. Superbugs can develop resistance much faster.

Patients urgently need new treatments, particularly for hard-to-treat infections such as those caused by Gram-negative bacteria, as well as Clostridium difficile (C.difficile), carbapenem-resistant Enterobacteriaceae, and drug-resistant gonorrhea. CARB-X is a new model that represents part of the solution. CARB-X supports the development of therapeutics, diagnostics, vaccines and other products to reduce the threat from drug-resistant infections.

Why are Gram-negative bacteria so tough to treat?Bacteria have evolved ways to prevent the entry of unwanted or toxic compounds such as antibiotics.Gram-negative bacteria have a double membrane along with a variety of efflux pumps that expel drugs out of the cell, making it difficult to design new antibiotics that target Gram-negative pathogens. Gram-positive bacteria have a single membrane barrier that is relatively easy to penetrate, so many types of antibiotics get into the cell.

Discovery of novel antibiotics* is not keeping pace with the emergence of new superbugs

0 0 0 0 0 01 1 1

5 5

7

9 33year gapNearly every antibioticin use today is based ona discovery made morethan 33 years ago.(daptomycin in 1984)

55year gapfor Gram-negatives (quinolones in 1962)

2

1890 1900

Num

ber

of a

ntib

iotic

cla

sses

dis

cove

red

or

pat

ente

d

1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 2017

No newly approved classes of antibiotics have been discovered

since 1962 for the most dangerous

types of bacteria – Gram negatives.

No newclasses at all discovered after 1984.

*This chart excludes bedaquiline, which is the first drug in a new class to treat tuberculosis.Source: Pew Charitable Trusts; Deak D, Powers JH, Outterson K, Kesselheim AS. Progress in the Fight Against Multidrug Resistant Bacteria?: A Review of FDA Approved Antibiotics 2010-2015. ANNALS OF INTERNAL MED. 2016 MAY 31. DOI: 10.7326/M16-0291.

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ANNUAL REPORT 2016-2017 | 7

Combating antibiotic resistant bacteria

Better stewardship for existing antibioticseliminate inappropriate use of these lifesaving drugs in both humans and animals.

Reduce the need for antibiotics by using alternative and nontraditional approaches to disease treatment and prevention.

Ensure that antibiotics are accessible and available to the people who need them.

Innovation to find new types of antibioticsSupport targeted research initiatives to overcome scientific challenges impeding the discovery of new antibiotics.

Address the complex barriers hindering the development of new treatment options for patients.

“Antibiotics transformed modern medicine but overuse and inappropriate use have led to dangerous bacteria developing deadly resistance. Drug discovery must go hand-in-hand with concerted action to ensure antibiotics of last resort are reserved for patients where first-line treatments will not work. And we must ensure these treatments are available in all countries for those who need them. That is why stewardship and fair access are integral to CARB-X support.”

— Tim JinksHead of Drug Resistant Infections, Wellcome Trust

“Antibiotic resistance is growing, and we are fast running out of treatment options. If we leave it to market forces alone, the new antibiotics we most urgently need are not going to be developed in time.”

— Dr Marie-Paule KienyAssistant Director-General for Health Systems

and Innovation, WHO

“As it funds innovative research on des-perately needed new candidate antibacterial agents & diagnostics, CARB-X is fundamen-tally shaping our global approach to treatment of drug-resistant Superbugs via its portfolio of both higher risk novel-mechanism products and lower risk known-mechanism products.”

— John RexChief Strategy Officer, CARB-X

“The companies funded by CARB-X rep-resent some of the best and most innovative science in the fight against drug-resistant bacteria. The Powered by CARB-X portfolio is the first-ever early stage R&D pipeline of this size to be supported as part of a global effort against drug-resistant bacteria.”

— Karen GallantGlobal Project Director, CARB-X

“Revitalizing the antibacterial pipeline is vital in enhancing national security, biode-fense, and global preparedness. CARB-X represents the type of novel public-private partnerships that are necessary to promote and accelerate medical countermeasure innovation.”

— Rick BrightBARDA Director

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| ANNUAL REPORT 2016-20178

FUNDING BARDA, Wellcome Trust and NIAID provide

$455 million over five years in funding and preclinical services

GOVERNANCE Joint Oversight Committee (JOC) provides

oversight, develops strategy and makes investment decisions

BOSTON UNIVERSITYADMINISTRATION

Hosted by a leading research university, with world-class research administrative support

BEST SCIENCE The Science Advisory Board reviews applications using rigorous scientific

criteria and recommends which projects should receive funding. The SAB is made up of world-renowned scientists and experts

EXPERT SUPPORT

Partners provide scientific and

business expertise to accelerate the research projects

CARB-X CARB-X core team ensures the

efficient leadership of the application and funding process and works closely with partners, funded companies and global networks to accelerate global

antibacterial innovation.

Only the most promising research is selected for non-dilutive

funding. Projects must target priority bacteria.

18 projects were awarded $41.6M in CARB-X’s first year,

with up to $52.6M more in milestone-based options.

Companies and research teams from around the world apply for

funding to support research against drug-resistant infections.

368 applications were reviewed in 2016-2017

HowCARB -X worksCARB-X provides financial and scientific support to accelerate the most promising drug-resistant bacterial infection research projects from around the world through the early stages of product development so they can attract additional private or public investment for clinical-stage development.

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ANNUAL REPORT 2016-2017 | 9

Iterum Therapeutics Ltd.Dublin, Ireland

Proteus IRCEdinburgh, Scotland

Redx Pharma PlcAlderley Park, UK

Oppilotech Ltd.London, UK

Eligochem Ltd.Sandwich, UK

AntabioLabège, France

Debiopharm International S.A.Lausanne, Switzerland

Bugworks Research India Pvt Ltd.Bangalore, India

Forge TherapeuticsSan Diego, CA

Cidara Therapeutics Inc.San Diego, CA

Achaogen Inc.South San Francisco, CA

Contrafect CorporationYonkers, NY

VenatoRx PharmaceuticalsMalvern, PA

Spero Therapeutics LLCCambridge, MA

Visterra Inc.Cambridge, MA

Tetraphase Pharmaceuticals Inc.Watertown, MA

Entasis Therapeutics Inc.Waltham, MA

Microbiotix Inc.Worcester, MA

EUROPE

NORTHAMERICA

EUROPE

ASIA

great science knowsno boundariesCARB-X supports the best science and most promising early stage R&D projects anywhere in the world. We are aggressively expanding our global outreach to ensure that no opportunity is lost in the battle against drug-resistant bacterial infections. In 2016-17, the Powered by CARB-X portfolio has 18 innovative projects in 6 countries targeting the most drug-resistant forms of Gram-negative bacteria.

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| ANNUAL REPORT 2016-201710

Company/Research

Team

Achaogen AKAO- LpxC Inhibitor Pseudomonas aeruginosa LpxC

Antabio PEI Pseudomonas Elastase Pseudomonas inhibitor aeruginosa

Bugworks Gyrox Gyrase-topoisomerase Gram- Research inhibitor negative activity

Cidara CD201 Bifunctional immunotherapy Acinetobacter + P. aeruginosa Therapeutics + Enterobacteriaceae

Gram- P. aeruginosa ContraFect negative lysins Recombinant lysin protein

Debiopharm Debio Narrow-spectrum Neisseria 1453 inhibitors of FabI Gonorrhoeae

Eligochem Helical AMP Helical Antimicrobial Peptide Gram-negative activity

Entasis ETX0282 Oral Gram-negative Gram-negative activity Therapeutics CPDP combination

Forge FG-LpxC LpxC Inhibitor Gram-negative activity Therapeutics

Iterum Sulopenem Oral and IV penem Gram-negative activity

Microbiotix T3SS Virulence modifier Pseudomonas Inhibitor aeruginosa

Gram- Oppilotech LPS Targets synthesis of LPS negative activity

Redx Pharma NBTI Dual-acting topoisomerase Acin. + P. aerug inhibitor + Enterobacteriaceae

Spero SPR741 Potentiator Gram-negative activity Therapeutics

Tetraphase TP-6076 Next-generation tetracycline Acinetobacter + Enterobacteriaceae Pharm

VenatoRx VNRX-PBP ß-lactamase Resistant PBP Inhibitor Entero- bacteriaceae

Visterra VIS705 Antibody-drug conjugate Pseudomonas aeruginosa

Project NewClass

Non-trad-itional

NewTarget

Project descriptionNovelty* Bacteria Targeted / Stage of Early Development

Urgency/Priority** Hit to

LeadLead

OptimizationPre-

Clinical Phase 1

Company/Research

Team

Proteus Rapid POC Optical bacterial POC Diagnostic Diagnostic imaging

Project Optimizationand Preparationfor Development

SystemIntegrationand Testing

FeasabilityDemonstration

ProductDevelopment

Project descriptionDevelopment Stage

* Novelty characterizations of new class and new target are established by CARB-X following the Pew Charitable Trusts pipeline analysis model. Pew defines a novel chemical class as a group of antibiotics that share a new common core molecular structure. Non-traditional products include lysins and monoclonal antibodies. ** Urgent and priority drug-resistant bacteria are determined by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Urgent/Critical priority Serious/High priority Serious/Medium priority. Stage of development is approximate as of July 2017.

The CARB-X portfolio comprises 18 early stage R&D projects investigating 8 new classes of antibiotics, 5 non-traditional antibiotics, 10 new molecular targets and a rapid diagnostic to determine the type of drug-resistant bacteria that is causing an infection.

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ANNUAL REPORT 2016-2017 | 11

2016-2017 in review in addition to establishing CARB-X and the Powered by CARB-X portfolio, we registered progress on several other fronts in our first year.

Partnership that produces resultsAmong the most significant achievements is the unique working relationship that CARB-X and its partners have forged together to identify, fund and support research projects. CARB-X represents an ambitious new model to drive investment into innovation and by any mea-sure, the new model is working. CARB-X requires that the companies receiving the funding commit significant investment of their own. While CARB-X grants are non-dilutive, we want our partner companies to have significant skin in the game. The result is an innovative pipeline that is growing.

Scientific rigor, efficiency and high standardsOur Science Advisory Board, which includes more than 60 world-renowned scientists and experts in drug and product development in the field of drug-resistant bacteria, has established high scientific and ethical standards for evaluating and selecting applications for funding. Our partners that provide support to funded projects are among the best in the world. These experts drive the high quality of the science in the CARB-X portfolio, working closely with experts in each of the funded companies.

Solutions at a global level Working closely with partners, CARB-X has been active in raising awareness about the rising global threat of drug-resistance and the solutions that we can help deliver. In July 2017, G20 leaders meeting in Hamburg, Germany, called on nations to support global antibiotic R&D efforts like CARB-X to develop new treatments for drug-resistant bacterial infections. CARB-X is a vital player in the global network of complementary R&D organizations focused on infectious disease, including GARDP, ND4BB, DRIVE-AB, and CEPI.

Raising awarenessThroughout the year, CARB-X has organized and participated in activities to raise awareness about drug resistance and the solutions that are needed at a global level.

Highlights include: • Articles published in prestigious journals including Lancet Infectious Diseases, Nature Review Drug Discovery and in the New York Times. • Launch of the Powered by CARB-X pipeline at Pew Charitable Trusts in Washington on March 30, 2017. The launch, which drew many government and industry leaders, generated significant coverage by the scientific, business and general media. • High-profile workshop in Geneva in May 2017, co-sponsored by CARB-X and DRIVE-AB, on global access and stewardship of antibiotics. Presentations, panel discussions and engagement with industry stakeholders at BIO2017 in San Diego in June 2017. In addition, our partners have held workshops with industry and academia. • Speaking engagements at public and sponsored events including The Atlantic’s ‘Pulse: On the Front Lines of Health Care’ in June 2017.

A solid foundationIn just one year, we have built a solid organization that is a vital part of the global solution to the rising threat of drug-resistant bacteria. We are also lean and effi-cient; in 2016-2017, more than 96 percent of CARB-X funds went directly into funding pipeline projects.

Building support for CARB-XOur funders, BARDA, NIAID and Wellcome Trust, have generously supported CARB-X in 2016-2017 and have made commitments for year two that exceed year one – a sure sign that CARB-X represents an exciting model to support development of promising products in the fight against drug-resistance. While our resources are formidable, CARB-X cannot support all applications worthy of funding. We are seeking new partnerships with countries and organizations around the world to expand our global reach.

“Our scientific and business success is driven by strong relationships with partners, investors and advisors. CARB-X’s funding and research support is helping us accelerate development of our novel antibiotic to treat Gram-negative bacteria and help fight the global ‘superbug’ threat.”

— Zachary ZimmermanCEO, Forge Therapeutics

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CARB-X is governed by the Joint Oversight Committee (JOC), which acts as the board of directors with full oversight for CARB-X operational and financial activities, ensuring the highest scientific and ethical standards. The JOC makes research investment decisions based on recommendations from the Science Advisory Board.

kevin outterson, J.D., LL.M.Executive Director & Principal Investigator, CARB-XProfessor and N. Neal Pike Scholar in Health and Disability LawBoston University

John H. Rex, MD, FACPChief Strategy Officer, CARB-XChief Medical Officer, F2G Ltd.Expert-in-Residence, Wellcome TrustOperating Partner, Advent Life Sciences

Joseph larsen, PhDDirector, Division of CBRN Medical CounterneasuresBiomedical Advanced Research and Development Authority (BARDA)Office of the Assistant Secretary for Preparedness and Response (ASPR)U.S. Department of Health and Human Services

Barry eisenstein, MDFormerly Merck, Cubist, Eli LillyChair, Science Advisory Board, CARB-X

tim Jinks, PhDHead of Drug Resistant Infections Priority ProgramWellcome Trust

edward whitingDirector of Policy and Chief of StaffWellcome Trust

tyler Merkeley, MS, MBACARB-X Program Manager

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response (ASPR)

U.S. Department of Health and Human Services

Dennis M. DixonChief, Bacteriology

and Mycology BranchNational Institute of Allergy and

Infectious Diseases (NIAID)National Institutes of Health (NIH)

U.S. Department of Health and Human Services

Christopher Houchens, PhDChief, Antibacterials

Division of CBRN Medical Countermeasures

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response (ASPR)

U.S. Department of Health and Human Services

Michael kurilla, MDDirector, Office of Biodefense,

Research Resources, and Translational Research

Associate Director, Biodefense Product Development

National Institute of Allergy and Infectious Diseases (NIAID)

National Institutes of Health (NIH) U.S. Department of Health and

Human Services

| ANNUAL REPORT 2016-201712

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ANNUAL REPORT 2016-2017 | 13

supporting great scienceOutstanding experts make up CARB-X’s Science Advisory Board (SAB). The SAB ensures the highest scientific standards in evaluating applications for CARB-X funding. Every member of the CARB-X SAB and JOC completes a conflicts of interest process and is excluded from participation in the review or approval of any application with which they have a conflict of interest. We thank them sincerely for their work.

Rosemarie Aurigemma, PhDDeputy Associate Director, Developmental Therapeutics Program Division of Cancer Treatment and DiagnosisNational Cancer Institute, NIH

Maureen J. Beanan, PhDProgram Officer, NIH/NIAID

Keith A. Bostian, PhDCEO, Institute for Life Science Entrepreneurship

David Boucher, PhDHealth Scientist, ASPR/BARDA

Patricia A. Bradford, PhDAntimicrobial Development Specialists, LLC

Liliana Brown, PhDProgram Officer, Office of Genomics and Advanced TechnologiesDivision of Microbiology and Infectious Diseases/NIAID/NIH

Karen Bush, PhDProfessor of Practice in Biotechnology, Indiana University

Joseph Campbell, PhDProgram Officer, Research Resources SectionOffice of Biodefense, Research Resources and Translational Research/DMID/NIAID

Daniel Chelsky, PhDCSO, Caprion Biosciences Inc.

Thomas ChenIndependent Consultant

Peter Coderre, PhD, MBAOwner, Antimicrobial Regulatory Consulting LLC

R.D.G. Cooper D.Sc., PhDCooper Consulting LLC

Patrice Courvalin, MD, FRCPDepartement de MicrobiologieInstitut Pasteur

Lloyd Czaplewski, PhDIndependent ConsultantDirector at Abgentis

Thomas J. Dougherty, PhDDept. of Microbiology & ImmunobiologyHarvard Medical School

Michael N. Dudley, PharmD, FIDSASenior Vice President, Head of R&DCo-Lead, Infectious Disease Global Innovation, The Medicines Company

Ann E. Eakin, PhDSenior Scientific Officer, DMIDNIAID/NIH

Paul Eder, PhDPrincipal and Senior Medical Diagnostics AdvisorTunnell Government Services, for BARDA

Michael Elisseou, PhDContractor, Division of CBRN Countermeasures, BARDA

Ronnie Farquhar, D. Phil.Morningside Ventures

Anthony Ford-Hutchinson, PhD Independent Consultant to the Pharmaceutical Industry

Francois Franceschi, PhDProgram Officer,Bacteriology and Mycology Branch NIH/NIAID

Humphrey Gardner, MDChief, Medical Oncology, Evelo Biosciences

Steven C. Gilman, PhDChairman and Chief Executive OfficerContrafect Corporation

Alan GoldbergSpecial Government Employee and SME Drug DevelopmentBARDA/ ASPR/ HHS

Mark J. Goldberger, MD, MPHIndependent ConsultantMark Goldberger MD, MPH LLC

Tina Guina, PhDProgram Officer, Drug DevelopmentDMID, NIAID, NIH

Raymond D. Harris, PhDProgram OfficerOffice of Biodefense, Research Resources and Translational Research, DMID/NIAID/NIH

Deborah T. Hung, MD, PhDCo-Director, Infectious Disease and Microbiome ProgramCore Institute MemberBroad Institute of MIT and HarvardAssociate Professor, Department of GeneticsHarvard Medical SchoolAssociate Professor, Department of Molecular Biology, Massachusetts General Hospital

Randall Kincaid, PhDSenior Scientific OfficerDivision of Microbiology and Infectious Diseases, NIAID/NIH

Jane M. Knisely, PhDProgram Officer, NIAID/NIH

Gerald R. Kovacs, PhDSenior Adviser, CMI Consulting for BARDA

Marina Kozak, PhDHealth Scientist, Division of CBRN CountermeasuresBARDA/ASPR/HHS

John S. Lee, PhDHealth Scientist, Diagnostics and Medical Devices Division (DMD)BARDA/ASPR/HHS

Malen Link, PhD, BiologistDivision of CBRN CountermeasuresASPR/HHS/BARD

Frederic J Marsik, PhDClinical Microbiology Consultant

Marielena Mata, PhDHead of Precision Medicine and Companion Diagnostics GSK

Chris Meda, MSChief Business Officer, IncellDx Inc. National Sponsorship Chair, Women in Bio, Board Director, Claremont BioSolution

Michael Merchlinsky, PhDScientific Program Manager, ASPR/BARDA

Linda A. Miller, PhDClinical MicrobiologistCMID Pharma Consulting, LLC

Paul F. Miller, PhDChief Scientific Officer, Synlogic

Tam Nguyen, PhDProgram Officer, NIAID

Sylvia A. Norman, PhDPresident & CEOSandhill Crane Diagnostics Inc.

David Oldach, MD, FIDSAChief Medical OfficerCempra Pharmaceuticals Inc.

Frederick B. Oleson, Jr., DScIndependent Consultant

Sharon Peacock, MBBS, PhD, FRCP, FRCPath, FMedSci, CBEProfessor of Clinical Microbiology, London school of Hygiene and Tropical MedicineNon-executive Director Adden-brooke’s Hospital, Cambridge

Steven J. Projan, PhD, F.A.A.M.Sr. Vice President R&D, Innovative Medicines Head Infectious Disease & Vaccines,MedImmune

Ryan T. Ranallo, PhDProgram OfficerDivision of Microbiology and Infectious Diseases NIAID

George Risi, MD, MScSenior Medical AdviserDivision of Clinical Development, BARDA

Bill Rodriguez, MDManaging DirectorDraper Richards Kaplan Foundation

M. Dominic Ryan, PhDDRI2, LLC

Helen Schiltz, PhDProgram Officer, Drug Development Section, Office of BioDefense, Research Resources, and Translational Research, DMID/NIAID/NIH

Oxana A. Selivanova, PhDInterdisciplinary ScientistBARDA/ASPR

Karen Joy Shaw, PhDCSO, Amplyx PharmaceuticalsPresident, Hearts Consulting Group

Richard Seabrook, PhD, MBAIndependent ConsultantSenior Advisor, Translational R&D at Catapult

Anita Sheoran, PhDProgram Officer, Drug Develop-ment, Division of Microbiology & Infectious Diseases, NIAID

Nicola Shepherd, PhDDirector, Bellows Consulting Ltd.

David ShlaesAnti-infectives Consulting, LLC, Retired

lynn l. silver, PhDLL Silver Consulting, LLC

Jared A. Silverman, PhDSenior Vice President, Research Kaleido Biosciences

Keith Spencer, PhDDirector Academic Liaison, GSK

Jeff Stein, PhDPresident & CEO,Cidara Therapeutics

Joyce Sutcliffe, PhDIndependent Antibacterial Consultant

Kimberly L. Taylor, PhDProject OfficerVaccine Development Section Office of Biodefense, Research Resources and Translational Research/DMID/NIAID

Fred C. Tenover, PhD D(ABMM)Vice President, Scientific Affairs,Cepheid

Ursula Theuretzbacher, PhDAntibiotic R&D expertCenter for Anti-Infective Agents

Brian N. Tse, PhDHealth ScientistBARDA/ASPR/HHS

Mark Wilcox, MD, FRCPathProfessor of Medical MicrobiologyUniversity of LeedsConsultant Microbiologist, Head of research and Development in Microbiology at Leeds Teaching Hospitals

Daniel Wolfe, PhDHealth Scientist, BARDA

Neil Woodford BSc PhD FRCPathProfessorHead, Antimicrobial Resistance and Healthcare Associated Infections (AMRHAI) Reference UnitNational Infection Service, Public Health England

Lanling Zou, MD, PhD Bacteriology Program OfficerChief, Translational Sciences SectionBMB/DMID/NIAID/NIH/DHHS

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| ANNUAL REPORT 2016-201714

Wellcome Trust and BARDA have committed $405 million in funding to CARB-X over five years for investment in preclinical antimicrobial research ($155.5 million from Wellcome Trust and $250 million from BARDA). NIAID has committed pre-clinical services valued at $50 million over five years to support the funded projects. These sums are allocated on a yearly basis.

AwARDs AnD eXPenDituRes (Fiscal Year ending 31 July 2018) (in millions)

Research funding awards Non-dilutive funding awards $81.94 93.5%

Business support to Powered by CARB-X companies 2.42 2.8%

general and Administrative 2.04 2.3% Salaries and administration 1.09 IT support .35 Consultants .49 Advisory Board .11

indirect costs 1.25 1.4%

totAl 87.65 100%

*CARB-X financial year is from August 1 to July 31.

CARB-X Year 2 Budget

Research funding awards

Business support to companies

General and Administrative

Indirect costs

More than 96 percent of CARB-X funds in 2017-2018 will go directly into funding pipeline projects.

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The power of science and collaboration will reduce the global threat of bacterial resistance.

Kevin Outterson with journalist Maryn McKenna (left) and Erika Kurt (right) at the Atlantic Pulse discussion on drug-resistant infections. The Atlantic video is available here.

This publication was supported by the Cooperative Agreement Number 6 IDSEP160030-02-01 from ASPR/BARDA and by an award from the Wellcome Trust. The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health or the Wellcome Trust.

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CARB-X765 Commonwealth Ave, Suite 1204Boston, MA [email protected]

“Antimicrobial resistance poses a catastrophic threat. If we don’t act now, any one of us could go into hospital in 20 years for minor surgery and die because of an ordinary infection that can’t be treated by antibiotics. And routine operations like hip replacements or organ transplants could be deadly because of the risk of infection. That’s why governments and organisations across the world... need to take this seriously. This is not just about government action. We need to encourage more innovation in the development of antibiotics – over the past two decades there has been a discovery void around antibiotics, meaning diseases have evolved faster than the drugs to treat them.”

— Dame Sally DaviesUK Chief Medical Officer


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